NCT02249780

Brief Summary

Evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation surgery. Create an objective basis for the decision whether or not to transplant the parathyroid glands. Avoide postoperative serum calcium and parathyroid hormone dosages, and thus abstention of systematic supplementation with calcium and vitamin D in case of good perfusion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 18, 2016

Status Verified

September 1, 2014

Enrollment Period

1.4 years

First QC Date

September 15, 2014

Last Update Submit

April 15, 2016

Conditions

Parathyroid Function Low Adverse Event

Keywords

Parathyroid gland angiographyParathyroid gland indocyanine green angiographyParathyroid gland indocyanine green fluoroscopy

Outcome Measures

Primary Outcomes (1)

  • Postoperative parathyroid function

    All patients will be reviewed at 10-15 days after surgery and blood tests will be done. Investigators will check the number of patients with serum calcium and parathyroid hormone in normal ranges at ten days after surgery in both arms of the study. Low parathyroid function will be diagnosed when corrected calcium \< 2mmol/l, and PTH \< 1.1 pmol/l.

    10 days after surgery

Secondary Outcomes (1)

  • Calcium and parathormone dosage after surgery

    10 days after surgery

Other Outcomes (1)

  • Economic impact

    From surgery day to 10 days after surgery

Study Arms (2)

New treatment

EXPERIMENTAL

In patients with at least one well perfused parathyroid gland on ICG parathyroid angiography, no postoperative parathyroid dosage and supplementation will be done. Calcium and parathormone dosage will be done 10 days after surgery.

Procedure: No postoperative parathyroid dosage and supplementationProcedure: ICG parathyroid angiography

Standart treatment

ACTIVE COMPARATOR

In those patients in whom at least on of the four parathyroid glands is well perused, postoperative parathyroid function test and parathyroid supplementation will be done. Calcium and parathormone dosage will be done at 24 hours and 10 days after surgery. Prophylactic supplementation of calcium and Vitamin D will be given.

Procedure: Postoperative parathyroid function testProcedure: ICG parathyroid angiographyDrug: Parathyroid supplementation

Interventions

Postoperative parathyroid function testPROCEDURE

Calcium and parathormone dosage at 24 hours and ten day after surgery

Standart treatment
No postoperative parathyroid dosage and supplementationPROCEDURE

The patients will be clinically followed for 24 hours after surgery and caclium and parathormone dosage will be done at ten days after surgery. No supplementation will be given.

Also known as: Parathiroid function testing
New treatment
ICG parathyroid angiographyPROCEDURE

Injection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal.

Also known as: Indoyanine green angiography, Indoyanine green fluoroscopy
New treatmentStandart treatment
Parathyroid supplementationDRUG

Supplementration with Calcimagon D3 Forte (1gr Calcium and 800 IU of 25-OH-vitamin D) from surgery day to up to 10 days afeter surgery.

Also known as: Hypocalcemia post thyroidectomy treatment
Standart treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing total thyroidectomy or a totalisation thyroid procedure.
  • Patients capable of understanding and able to understand the study.
  • Values visually 2 and ICG 2

You may not qualify if:

  • Parathyroid disease or prior parathyroidectomy
  • Lack of informed consent
  • Altered mental status of the patient.
  • ICG values \<2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Geneva

Geneva, Canton of Geneva, 1205, Switzerland

Location

Related Publications (1)

  • Vidal Fortuny J, Sadowski SM, Belfontali V, Guigard S, Poncet A, Ris F, Karenovics W, Triponez F. Randomized clinical trial of intraoperative parathyroid gland angiography with indocyanine green fluorescence predicting parathyroid function after thyroid surgery. Br J Surg. 2018 Mar;105(4):350-357. doi: 10.1002/bjs.10783. Epub 2018 Feb 6.

    PMID: 29405252DERIVED

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Frédéric Triponez, Professor

    University Hospital, Geneva

    STUDY DIRECTOR

  • Wolfram Karenovics, SPR

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

  • Frédéric Ris, Consultant

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

  • Valentina Belfontali, Resident

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

  • Jordi Vidal Fortuny, SPR

    University Hospital, Geneva

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chef de clinique

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 26, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 18, 2016

Record last verified: 2014-09

Locations

CH(1)